In an article published in the Nov. 7 issue of the Journal of the American Medical Association (JAMA), Pronovost, an anesthesiologist and critical care specialist, and a team of Johns Hopkins researchers adapted elements of the well-known Users' Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice, to construct what they say are guidelines that hospitals can use to ensure validity and accuracy in patient safety reporting.
"The guide has been used successfully for years to help clinicians evaluate the validity and accuracy of research data they might want to use in their own practice," says Pronovost. "We propose using the same principles to evaluate the validity and accuracy of the methods used by an institution to gauge patient safety."
Like the clinical practice assessments, the new guidelines, Pronovost says, address three key questions: Are the measures important, are they valid and are they useful for the goal intended, in this case to improve safety in health care organizations? These larger concepts are addressed in an assessment tool that comprises some 30 questions, such as: Is the measure required by an external group or agency? Is the measure supported by empiric evidence or a consensus of experts? Does the measure have face validity - do clinicians believe that improvement in performance on the measure will be associated with improved patient outcomes? Is the risk for selection bias minimized?
Patient safety reporting came to the forefront in 1999 after the Institute of Medicine issued its report "To Err is Human," which documented widespread risk to patients. In response, the Centers for Medicare and Medicaid Service (CMS) and the Joint Commission began requiring all hospitals to submit annual patient safety reports.
The problem with these reports is they were essentially "snapshots" rather than long-term system analyses, according to Pronovost.
For example, they would identify whether pneumonia patients received antibiotics within a specific time frame or if statins were administered to heart attack patients. In an article published in the Oct. 17 issue of the Journal of the American Medical Association, Pronovost and his team illustrated some of the limitations of this type or reporting.
"One institution advertised on its Web site that its rate of staph infection is zero but did not say how many people were sampled or whether this represents one month of results or 10 years," says Pronovost. Examples of problematic reports on health care organization Web sites are easy to find.
A quick and unscientific search of the Internet revealed many examples. One hospital reported that it saved 242 lives over 18 months (four lives/1,000 discharges). But, the sample size, methods of risk adjustment, and a measure of precision (e.g., confidence intervals) for the mortality estimates were not given. Another hospital Web site stated that 90 percent of pneumonia patients were screened and given pneumococcal vaccination, while the CMS's Hospital Compare Web site (www.hospitalcompare.hhs.gov) on the same day reported that 64 percent of patients were vaccinated.
"It's essentially a snapshot of care," says Pronovost. "To best assess the current level of safety, what's being done to improve it and whether it's getting better, we need all the elements that make up the big picture."
Source: John Hopkins